BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MODULAR HUMERAL HEAD EXTENDED ARTICULAR SURFACE

    MDR report key: 6442081 · Received March 29, 2017

    Report

    Report Number
    0001825034-2017-02192
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    March 2, 2017
    Report Date
    June 1, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWT
    PMA / PMN Number
    PK030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE HOSPITAL DISCARDING IT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL PRODUCTS: COMPREHENSIVE STEM, CATALOG#: 113651, LOT#: 278610, JUGGERKNOT. CATALOG#: 912068, LOT#: 221930, JUGGERKNOT, CATALOG#: 912068, LOT#: 743260, JUGGERKNOT. CATALOG#: 912068, LOT#: 238220, JUGGERKNOT, CATALOG#: 912073, LOT#: 962760, GLENOID POST. CATALOG#: PT-113950, LOT#: 794190, HYBRID GLENOID BASE, CATALOG#: 113952, LOT#: 664160.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE WAS USED FOR TREATMENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ROOT CAUSE DETERMINED TO BE PATIENT CONDITION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT UNDERWENT SHOULDER REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO DISLOCATION SECONDARY TO ROTATOR CUFF FAILURE DUE TO UNKNOWN REASONS. THE PATIENT'S HUMERAL HEAD AND STEM WERE REMOVED AND THE GLENOID WAS LEFT IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224480 BIO-MODULAR HUMERAL HEAD EXTENDED ARTICULAR SURFACE PROSTHESIS, SHOULDER KWT BIOMET ORTHOPEDICS NI 953860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R